Definition

QC management includes establishing ranges, monitoring shifts and trends, and linking corrective actions to instrument maintenance records.

Workflow

Workflows route failed QC to supervisors, optionally block patient reporting for affected assays, and document repeat QC acceptance.

Implementation

Rollouts should validate lot changes after reagent switches and recalibration events with defined signatories.

Compliance

ISO 15189 and CAP checklists expect demonstrable QC review; software assists but does not replace SOP adherence.

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